At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 674 enrolled

Drug / intervention

Nicoderm Transdermal Patch +1 moredrug

Likely dose

Nicoderm Transdermal Patch 21mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00326781

NCT00326781Phase 4Completed

Compare CT.gov

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

University of Pennsylvania·interventional·Posted May 17, 2006·Updated Aug 24, 2010

In Brief

A Phase 4 clinical trial evaluating Nicoderm Transdermal Patch and Nicotine Nasal Spray for Smoking. Completed, enrolled 674 participants across 1 site.

Detailed Summary

The purpose of this research study is to: 1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and 2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSmoking

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 4CompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 1999

Primary CompletionAug 2004

First PostedMay 2006

TodayJul 2026

First PostedMay 17, 2006

Enrollment StartDec 1, 1999

Primary CompletionAug 1, 2004

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 20.1 years ago

Interventions

Nicoderm Transdermal Patchdrug

The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.

Nicotine Nasal Spraydrug

8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.